Navigation Links
Sanofi Pasteur announces FDA approval of menactra meningococcal conjugate vaccine indication for infants
Date:4/25/2011

Swiftwater, PA April 22, 2011 - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has granted licensure to expand the indication for its meningococcal conjugate vaccine, Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), to include a two-dose schedule for infants and children 9 months through 23 months of age. This is the first U.S. approval of a meningococcal vaccine for this age group.

"Licensure of Menactra vaccine for infants as young as 9 months of age gives the opportunity to help protect infants against this potentially deadly disease when the likelihood of exposure supports a need for early protection," said Stephen I. Pelton, MD, Professor of Pediatrics and Epidemiology, Boston University Schools of Medicine and Public Health and Chief, section of Pediatric Infectious Diseases, Boston Medical Center.

Meningococcal disease is a rare but deadly disease caused by the bacterium Neisseria meningitidis. The disease can progress quickly and take the life of a child within 24 hours. Menactra vaccine was the first quadrivalent conjugate vaccine licensed in the United States for active immunization against meningococcal disease caused by the serogroups contained in the vaccine (A, C, Y and W-135). More than 36 million doses of Menactra vaccine have been distributed in the United States since its licensure in 2005.

The FDA approval of Menactra vaccine for infants was based on results of one Phase II and three Phase III modified single-blind, controlled, multicenter trials in which more than 3,300 infants from the United States received Menactra vaccine using a two-dose schedule, starting as young as 9 months of age. Results from these studies showed that 2 doses of Menactra vaccine given 3 months apart elicit a robust immune response against the serogroups included in the vaccine. The studies also showed that measles-mumps-rubellavaricella vaccine (MMRV) and pneumococcal conjugate vaccine (PCV7) can be administrated concomitantly with Menactra vaccine in children. Vaccine related reactions included swelling, tenderness at injection site, and irritability.

"The approval of Menactra vaccine for infants is a significant advancement toward potentially eliminating the threat of this serious disease in this vulnerable population for included serogroups," said Michael Decker, MD, MPH, vice president, scientific and medical affairs at Sanofi Pasteur. "With this approval, it is now possible to help protect persons from 9 months through 55 years of age."


'/>"/>

Contact: Amy Ba
Amy.ba@sanofipasteur.com
570-957-0717
Cooney Waters Group, Inc.
Source:Eurekalert

Related medicine news :

1. Eggs Being Produced by Recall Farms Safe, if Pasteurized, Experts Say
2. Government of Canada announces results in fight to save women and children with malaria
3. Oxford Nanopore announces licence agreement with Harvard University for graphene DNA sequencing
4. Elsevier Health Middle East announces publication of first bilingual medical title
5. International Vaccine Institute announces launch of Dengue Vaccine Initiative
6. Washington Life Sciences Discovery Fund announces grants to commercialize promising technologies
7. MSD Wellcome Trust Hilleman Laboratories announces first project
8. AIUM announces ultrasound practice accreditation in fetal echocardiography
9. American Physical Society announces Physical Review X
10. Beth Israel Deaconess Medical Center announces new AAAS Fellows
11. NARSAD announces $12.6 million for new generation of brain and behavior research
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... ... February 10, 2016 , ... AHRA: ... winner and inspirational speaker Jan Fox will serve as keynote speaker at the ... provide participants with tools to more effectively communicate with their own organizational staff ...
(Date:2/10/2016)... Baltimore, MD (PRWEB) , ... February 10, 2016 ... ... (ADP) to make Everseat digital self-scheduling readily available to physicians. The ... so patients can find and select appointments via Everseat’s free mobile app. , ...
(Date:2/10/2016)... Denver, Colorado (PRWEB) , ... February 10, 2016 , ... ... now, but cannabis enthusiasts in the state still face a lot of restrictions as ... “retail marijuana is intended for private, personal use” and that cannabis “may not be ...
(Date:2/10/2016)... ... February 09, 2016 , ... According to a recent ... increase in the number of patients under the age of 30. According to Southern ... in their offices, and may indicate an overall shift in the rapidly growing social ...
(Date:2/9/2016)... Fort Worth, Texas (PRWEB) , ... February 09, ... ... restoration and reconstruction firm helping businesses recover after a disaster, announced today the ... restoration service companies in Hawaii. , “Investing in like-minded companies who ...
Breaking Medicine News(10 mins):
(Date:2/10/2016)... , February 10, 2016 Puerto Rico ... Puerto Rico Healthcare and Life Sciences Report 2016 ... page Puerto Rico Healthcare and Life Sciences Report 2016 ... into the fifth largest territory in the world for pharma ... device and diagnostics manufacturing, and more universities per square mile ...
(Date:2/10/2016)... , Feb. 10, 2016 Convergence ... confluence of various technologies that results in ... unavailable. These opportunities create a cyclical system ... turn, drives the development of new technologies. ... characterized by technology convergences, which are constantly ...
(Date:2/10/2016)... PRINCETON, New Jersey and OR AKIVA, ... Regentis Biomaterials Ltd., a leader ... of its Series D investment round on February 5, ... Haisco Pharmaceutical Group ("Haisco"), a leading Chinese pharmaceutical ... Medica Partners, SCP Vitalife Partners, Generali Financial Holdings and ...
Breaking Medicine Technology: